SIST EN ISO 7864:2000
(Main)Sterile hypodermic needles for single use (ISO 7864:1993)
Sterile hypodermic needles for single use (ISO 7864:1993)
Specifies the following requirements for needles of nominal outside diameters 0,3 mm and 1,2 mm: nomenclature for components, cleanliness, limits for acidity and alkalinity, size designation, colour coding, needle hub, sheath, needle tube, needle point, performance, packaging, labelling, storage container, transport wrapping.
Sterile Einmal-Injektionskanülen (ISO 7864:1993)
In dieser Internationalen Norm werden die Anforderungen für sterile Einmal-Injektionskanülen mit einem Nenn-Außendurchmesser von 0,3 mm bis 1,2 mm festgelegt. Die Norm bezieht sich nicht auf Kanülen in der Zahnheilkunde.
Aiguilles hypodermiques stériles, non réutilisables (ISO 7864:1993)
La présente Norme internationale fixe les prescriptions des aiguilles hypodermiques stériles, non réutilisables, ayant un diamètre extérieur nominal compris entre 0,3 mm et 1,2 mm. Elle ne s'applique pas aux aiguilles dentaires.
Sterilne podkožne igle za enkratno uporabo (ISO 7864:1993)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7864:2000
01-januar-2000
Sterilne podkožne igle za enkratno uporabo (ISO 7864:1993)
Sterile hypodermic needles for single use (ISO 7864:1993)
Sterile Einmal-Injektionskanülen (ISO 7864:1993)
Aiguilles hypodermiques stériles, non réutilisables (ISO 7864:1993)
Ta slovenski standard je istoveten z: EN ISO 7864:1995
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7864:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7864:2000
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SIST EN ISO 7864:2000
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SIST EN ISO 7864:2000
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SIST EN ISO 7864:2000
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SIST EN ISO 7864:2000
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SIST EN ISO 7864:2000
IS0
INTERNATIONAL
STANDARD 7864
Third edition
1993-05-l 5
Sterile hypodermic needles for single use
Aiguilles hypodermiques st&iles, non r&dilisables
Reference number
IS0 7864: 1993(E)
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SIST EN ISO 7864:2000
IS0 7864:1993(E)
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
2 Normative references
1
3 Nomenclature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
4 Cleanliness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
I
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Limits for acidity or alkalinity
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 Limits for extractable metals
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
7 Size designation
-0
2
8 Colour coding . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
2
9 Needle hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Sheath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
3
11 Needle tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
12 Needle point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
13 Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
14 Packaging ,.,.,.
5
15 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annexes
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A Method for preparation of extracts
B Example of method for determination of fragment production from
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
rubber closures
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
C Symbol for “do not reuse”
II
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
D Bibliography
0 IS0 1993
All rights reserved. No part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without
permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Genhve 20 l Switzerland
Printed in Switzerland
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SIST EN ISO 7864:2000
IS0 7864:1993(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard IS0 7864 was prepared by Technical Committee
ISO/TC 84, Medical devices for injections, Sub-Committee SC 1,
Syringes, needles and intravascular catheters for single use.
This third edition cancels and replaces the second edition
(IS0 7864:1988), of which it constitutes a technical revision.
The major differences between this edition and the 1988 edition are as
follows.
This International Standard specifies the use of needle tubing com-
a)
plying with IS0 9626. As requirements for metallic materials,
stiffness, resistance to breakage and resistance to corrosion are
given in IS0 9626, they have been deleted from this International
Standard. The preparation of IS0 9626 has also allowed the intro-
duction of new, smaller outside diameters of needle tubing and of
tubing of thin- and extra-thin-walled types into this International
Standard. In order to avoid inhibiting innovation, this International
Standard no longer recommends combinations of needle diameter
and length.
b) Additional information and guidance have been introduced on needle
point geometry and fragmentation properties, and the limited num-
ber of tests for toxicity given in the 1988 edition has been replaced
by an informative annex that lists a significantly greater number of
relevant biological tests.
c) This International Standard permits the use on package labelling of
the IS0 symbol for “do not re-use”, but continues to require the
written word. Manufacturers are encouraged to use the symbol so
as to increase familiarity with it among purchasers and users.
Annex A forms an integral part of this International Standard. Annexes
B, C and D are for information only.
. . .
III
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SIST EN ISO 7864:2000
IS0 7864:1993(E)
Introduction
This International Standard covers sterile hypodermic needles intended
for single use primarily in humans.
This International Standard does not give requirements or test methods
for freedom from biological hazard because international agreement
upon the methodology and the pass/fail criteria is incomplete. Guidance
on biological tests relevant to hypodermic needles is given in
IS0 109934, and it is suggested that manufacturers take this guidance
into account when evaluating products. Such an evaluation should in-
clude the effects of the process whereby the needles are sterilized.
However, national regulations may exist in some countries, and these
will override the guidance in IS0 109934.
Plastics materials to be used for the construction of needles are not
specified as their selection will depend to some extent upon the design,
process of manufacture and method of sterilization employed by indi-
vidual manufacturers. The materials should be compatible with injection
fluids included in relevant pharmacopoeiae.
Hypodermic needles specified in this International Standard are in-
tended for use with hypodermic syringes specified in IS0 595 and
IS0 78864. They will also fit syringes of types 1 and 2 specified in
IS0 8537.
In some countries, national pharmacopoeiae or government regulations
are legally binding and their requirements may take precedence over
this International Standard.
iv
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SIST EN ISO 7864:2000
IS0 7864:1993(E)
INTERNATIONAL STANDARD
Sterile hypodermic needles for single use
IS0 8601:1988, Data elements and interchange for-
1 Scope
- Information interchange - Representation of
mats
dates and times.
This International Standard specifies requirements
for sterile hypodermic needles for single use of
IS0 9626:1991, Stainless steel needle tubing for the
nominal outside diameters 0,3 mm and I,2 mm.
manufacture of medical devices.
It does not apply to dental needles.
3 Nomenclature
The nomenclature for components of hypodermic
needles for single use is shown in figure 1 together
2 Normative references
with the designation for length I; nomenclature for
needle points is shown in figure 2.
The following standards contain provisions which,
through reference in this text, constitute provisions
of this International Standard. At the time of publi-
4 Cleanliness
cation, the editions indicated were valid. All stan-
dards are subject to revision, and parties to
When inspected by normal or corrected-to-normal
agreements based on this International Standard
vision without magnification under an illuminance
are encouraged to investigate the possibility of ap-
of 300 lx to 700 Ix, the surface of the hypodermic
plying the most recent editions of the standards in-
needle tube shall appear free from particles and
dicated below. Members of IEC and IS0 maintain
extraneous matter.
registers of currently valid International Standards.
When examined under x 2,5 magnification, the hub
socket shall appear free from particles and extrane-
IS0 594.1:1986, Conical fittings with a 6 % (Luer) ta-
ous matter.
per for syringes, needles and certain other medical
equipment - Part 1: General requirements.
5 Limits for acidity or alkalinity
IS0 594.2:1991, Conical fittings with a 6 % (Luer) ta-
per for syringes, need/es and certain other medical
When determined with a laboratory pH meter and
equipment - Part 2: Lock fittings.
using a general purpose electrode, the pH value of
an extract prepared in accordance with annex A
IS0 3696:1987, Water for analytical laboratory use -
shall be within one unit of pH of that of the control
Specification and test methods.
fluid.
IS0 6009:1992, Hypodermic needles for single use -
6 Limits for extractable metals
Co/our coding for identification.
IS0 7886-l : A Sterile hypodermic syringes for single When tested by a recognized microanalytical
use - Part I: ‘Syringes for manual use. method, for example by an atomic absorption
1) To be published.
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SIST EN ISO 7864:2000
IS0 7864:1993(E)
method, an extract prepared in accordance with an-
ance with IS0 6009 applied to the unit container
nex A shall, when corrected for the metals content
and/or part of the needle assembly such as the
of the control fluid, contain not greater than a com- needle hub or the sheath.
bined total of 5 mg/l of lead, tin, zinc and iron. The
cadmium content of the extract shall, when cor-
rected for the cadmium content of the control fluid,
9 Needle hub
be lower than 0,l mg/l.
9.1 Conical fitting
7 Sire designation
The conical socket of the hypodermic needle hub
The size of hypodermic needle shall be designated
shall be in accordance with IS0 594-l.
by the following:
If the hub has a locking fitting, it shall be in accord-
a) the nominal outside diameter of the needle tube,
ance with IS0 594-2.
expressed in millimetres;
b) the nominal length of the needle tube, expressed
9.2 Colour of hub
in millimetres.
The hub shall be made either of pigmented or of
The size shall be referred to as “the designated
unpigmented material. If pigmented, the colour shall
metric size” and shall be expressed in millimetres.
be in accordance with IS0 6009.
EXAMPLE
0,8 x 40
10 Sheath
If a separate needle sheath is provided, it shall be
8 Colour coding
made either of pigmented or of unpigmented ma-
The nominal outside diameter of hypodermic nee- terial. If pigmented, the colour shall be in accord-
dles shall be identified by colour coding in accord- ance with IS0 6009.
Key
1 Hub
2 Jointing medium
3 Needle tube
4 Sheath
Figure 1 - Example of typical hypodermic needle and sheath for single use
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SIST EN ISO 7864:2000
View showing varlant when primary
bevel intersects needle tip
Needle rotated by angle fl
-
I-
d, Out&de dfameter of needle tube C2 Left secondary bevel length
bt Primary bevel angle
df lnslde diameter of needle tube
H Secondary bevel angle
A Point length
BO Primary bevel nomlnal length BO - ( A-& ) p Tip angle
0, Right secondary bevel rotation angle
8, Right primary bevel length
B2 Lett prlmary bev,el length S2 Left secondary bevel rotation angle
CO Secondary bevel nominal length J Combined secondary bevel angle
C, Right secondary bevel length
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SIST EN ISO 7864:2000
IS0 7864:1993(E)
needle points shown are of configurations com-
11 Needle tube
monly manufactured: other configurations may be
equally satisfactory. It may not be necessary to use
11 .l General
all the dimensions when describing the point con-
figur
...
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